Bisco, Inc.

FDA 510(k) & PMA Approved Devices — 85 products

Total Devices85

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K250156	Choice 2 DC	EMA	2025-07-11	View
510(k)	K242816	Quantium	EBF	2024-12-17	View
510(k)	K192007	TheraBase, TheraBase Ca	EMA	2020-03-17	View
510(k)	K182917	FluoroCal	LBH	2019-11-18	View
510(k)	K180344	TheraCal DC	EJK	2018-04-05	View
510(k)	K171147	REVEAL Bulk	EBF	2017-08-04	View
510(k)	K162598	HAPI Seal	EBC	2017-05-23	View
510(k)	K163171	CeraClean	PME	2017-04-14	View
510(k)	K161051	All-Bond Universal w/BAC (not finalized)	KLE	2016-09-09	View
510(k)	K161256	TheraCem	EMA	2016-07-29	View
510(k)	K123653	SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)	LBH	2013-06-03	View
510(k)	K113401	ORTHO-1(NOT FINALIZED)	DYH	2012-02-07	View
510(k)	K112118	DREAMBOND	KLE	2011-11-17	View
510(k)	K103514	PRO-V COAT	EBG	2011-05-25	View
510(k)	K102844	ALL-BOUND 3	KLE	2010-10-29	View
510(k)	K101787	DUOLINK II	EMA	2010-10-08	View
510(k)	K101485	ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E	KLE	2010-08-26	View
510(k)	K093470	CORE-FLO D/C	EBF	2010-02-17	View
510(k)	K091705	PRIMER PLUS	KLE	2009-08-28	View
510(k)	K082449	BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012	EMA	2008-09-25	View